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Krispy Kreme Declares Quarterly Dividend

Krispy Kreme Declares Quarterly Dividend

CHARLOTTE, N.C.–(BUSINESS WIRE)–
The Board of Directors of Krispy Kreme, Inc. (the “Company” or “Krispy Kreme”) (NASDAQ: DNUT) today announced a quarterly cash dividend of $0.035 per share of common stock, in accordance with the Company’s dividend policy. The dividend was declared yesterday, September 15, 2022. The dividend will be paid on November 9, 2022, to shareholders of record on October 26, 2022.

About Krispy Kreme

Headquartered in Charlotte, N.C., Krispy Kreme is one of the most beloved and well-known sweet treat brands in the world. Our iconic Original Glazed® doughnut is universally recognized for its hot-off-the-line, melt-in-your-mouth experience. Krispy Kreme operates in over 30 countries through its unique network of doughnut shops, partnerships with leading retailers, and a rapidly growing ecommerce and delivery business. Our purpose of touching and enhancing lives through the joy that is Krispy Kreme guides how we operate every day and is reflected in the love we have for our people, our communities and the planet. Connect with Krispy Kreme Doughnuts at www.KrispyKreme.com, or on one of its many social media channels, including www.Facebook.com/KrispyKreme, and www.Twitter.com/KrispyKreme.

Investor Relations

Rob Ballew, VP of Investor Relations

[email protected]

Financial Media

Edelman for Krispy Kreme, Inc.

Allie McLarty & Ashley Firlan, [email protected]

KEYWORDS: North Carolina United States North America

INDUSTRY KEYWORDS: Restaurant/Bar Food/Beverage Retail Supermarket Convenience Store

MEDIA:

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Scholar Rock to Present at Upcoming ACCP Annual Meeting and World CB & CDx Summit

Scholar Rock to Present at Upcoming ACCP Annual Meeting and World CB & CDx Summit

CAMBRIDGE, Mass.–(BUSINESS WIRE)–
Scholar Rock (NASDAQ: SRRK), a Phase 3, clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, today announced two upcoming presentations, – one at the American College of Clinical Pharmacology Annual Meeting being held September 25-27 in Bethesda, Maryland, and another at the 12th Annual World Clinical Biomarkers & CDx Summit being held September 26-29 in Boston, Massachusetts.

The presentations will provide insight into SRK-181, a selective inhibitor of latent TGFβ1 activation being developed with the aim of overcoming primary resistance to checkpoint therapy in advanced cancer patients. Combination therapy with selective TGFβ1 blockade may modulate the tumor microenvironment, allowing for immune cell infiltration and potential improvements in the response rate and survival time of cancer patients.

Specifically, the ACCP presentation will include new pharmacokinetic data from the Phase 1 dose escalation study (DRAGON Part A). The presentation at the World Clinical Biomarkers & CDx Summit includes a discussion of pre-clinical validation studies to assess biomarker utility, overcoming challenges and hurdles that create barriers to assay translatability to the clinic, and early clinical biomarker data including image-based analysis.

Details of the presentations are as follows:

ACCP Annual Meeting:

Title: Preliminary Population Pharmacokinetic Modeling of SRK-181 from Phase 1 Dose Escalation Study

Presentation Type: Poster 015

Presenter: Amanda Hoerres, PharmD, independent consultant for Scholar Rock and Senior Scientist II, Clinical Pharmacologist, Vanadro Consulting

Date/Time: September 25, 5-7 p.m. ET

12th Annual World Clinical Biomarkers & CDx Summit:

Title: Development of a Comprehensive Biomarker Strategy for the Latent TGFβ1 Inhibitor SRK-181 Phase 1 Clinical Trial, DRAGON

Presentation Type: Oral

Presenter: Si Tuen Lee-Hoeflich, Senior Director, Translational Sciences at Scholar Rock

Date/Time: September 28, 3:25 p.m. ET

The presentations will be made available in the Publications & Posters section of Scholar Rock’s website following the conferences.

For conference information, visit https://accp1.org/ and https://world-cdx.com/

About SRK-181

SRK-181 is a selective inhibitor of TGFβ1 activation being developed to overcome primary resistance to checkpoint inhibitor therapy, such as anti-PD-(L)1 antibodies. TGFβ1 is the predominant TGFβ isoform expressed in many human tumor types. Based on analyses of various human tumors that are resistant to anti-PD-(L)1 therapy, data suggest TGFβ1 is a key contributor to the immunosuppressive tumor microenvironment, excluding and preventing entry of cytotoxic T cells into the tumor, thereby inhibiting anti-tumor immunity.(1) Scholar Rock believes SRK-181, which specifically targets the latent TGFβ1 isoform, has the potential to overcome this immune cell exclusion and induce tumor regression when administered in combination with anti-PD-(L)1 therapy while potentially avoiding toxicities associated with non-selective TGFβ inhibition. The DRAGON Phase 1 proof-of-concept clinical trial (NCT04291079) in patients with locally advanced or metastatic solid tumors is ongoing. SRK-181 is an investigational product candidate and its efficacy and safety have not been established. SRK-181 has not been approved for any use by the FDA nor any other regulatory agency.

(1) Martin et al., Sci. Transl. Med. 12: 25 March 2020

About Scholar Rock

Scholar Rock is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of serious diseases in which signaling by protein growth factors plays a fundamental role. Scholar Rock is creating a pipeline of novel product candidates with the potential to transform the lives of patients suffering from a wide range of serious diseases, including neuromuscular disorders, cancer, and fibrosis. Scholar Rock’s approach to targeting the molecular mechanisms of growth factor activation enabled it to develop a proprietary platform for the discovery and development of monoclonal antibodies that locally and selectively target these signaling proteins at the cellular level. By developing product candidates that act in the disease microenvironment, the Company intends to avoid the historical challenges associated with inhibiting growth factors for therapeutic effect. Scholar Rock believes its focus on biologically validated growth factors may facilitate a more efficient development path. For more information, please visit www.ScholarRock.com or follow Scholar Rock on Twitter (@ScholarRock) and LinkedIn (https://www.linkedin.com/company/scholar-rock/). Investors and others should note that we communicate with our investors and the public using our company website www.scholarrock.com, including, but not limited to, company disclosures, investor presentations and FAQs, Securities and Exchange Commission filings, press releases, public conference call transcripts, and webcast transcripts, as well as on Twitter and LinkedIn. The information that we post on our website or on Twitter or LinkedIn could be deemed to be material information. As a result, we encourage investors, the media and others interested to review the information that we post there on a regular basis. The contents of our website or social media shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.

Scholar Rock® is a registered trademark of Scholar Rock, Inc.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Scholar Rock’s future expectations, plans and prospects, including without limitation, Scholar Rock’s expectations regarding its growth, strategy, and progress and indication selection and development timing, the ability of any product candidate to perform in humans in a manner consistent with earlier nonclinical, preclinical or clinical trial data, and the potential of its product candidates and proprietary platform. The use of words such as “may,” “might,” “could,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify such forward-looking statements. All such forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, without limitation, Scholar Rock’s ability to provide the financial support, resources and expertise necessary to identify and develop product candidates on the expected timeline, the data generated from Scholar Rock’s nonclinical and preclinical studies and clinical trials, and Scholar Rock’s ability to manage expenses and to obtain additional funding when needed to support its business activities, as well as those risks more fully discussed in the section entitled “Risk Factors” in Scholar Rock’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, as well as discussions of potential risks, uncertainties, and other important factors in Scholar Rock’s subsequent filings with the Securities and Exchange Commission. Any forward-looking statements represent Scholar Rock’s views only as of today and should not be relied upon as representing its views as of any subsequent date. All information in this press release is as of the date of the release, and Scholar Rock undertakes no duty to update this information unless required by law.

Scholar Rock:

Investors

Rushmie Nofsinger

Scholar Rock

[email protected]

[email protected]

857-259-5573

Media

Ariane Lovell

Finn Partners

[email protected]

[email protected]

917-565-2204

KEYWORDS: Massachusetts United States North America

INDUSTRY KEYWORDS: Health Clinical Trials Research Pharmaceutical Science Biotechnology

MEDIA:

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Romeo Power Reminds Stockholders to Tender Shares for Nikola Transaction Before September 26, 2022 Deadline

Romeo Power Reminds Stockholders to Tender Shares for Nikola Transaction Before September 26, 2022 Deadline

Company explains process for stockholders to properly tender shares to the exchange agent or request assistance with their transaction

  • Romeo stockholders must tender their shares by midnight, Eastern Time, at the end of the day Monday, September 26, 2022
  • If less than a majority of outstanding Romeo shares are tendered, the Offer cannot be completed by Nikola
  • Romeo stockholders are encouraged to contact Alliance Advisors for assistance with tender offer transactions, +1 (855) 643-7453 or [email protected]
  • Stockholders who hold Romeo stock through a broker or nominee should contact their broker or nominee to tender
  • Romeo’s Board of Directors unanimously recommends all stockholders tender their shares
  • The proposed exchange ratio represents an approximately 34% premium based on Nikola’s and Romeo’s closing share price on July 29, 2022

CYPRESS, Calif.–(BUSINESS WIRE)–
Romeo Power, Inc. (“Romeo”) (NYSE: RMO), an energy storage technology company focused on designing and manufacturing lithium ion battery products and packs for vehicle electrification, today reminds all Romeo stockholders to tender their shares into the exchange offer (“the Offer”) by Nikola Corporation (NASDAQ: NKLA) to purchase all outstanding shares of common stock of Romeo by September 26, 2022 at midnight Eastern Time.

On August 1, 2022, Nikola and Romeo jointly announced they had entered into a definitive agreement for this all-stock transaction in which Romeo stockholders will receive 0.1186 of a share of Nikola common stock for each Romeo share, representing an equity value of approximately 4.5% pro forma ownership of Nikola. The exchange ratio represents an approximately 34% premium to Nikola’s and Romeo’s July 29, 2022 closing share prices and values Romeo’s equity at approximately $144 million.

As further described in Romeo’s public filings, Romeo’s Board of Directors unanimously determined that, after a comprehensive evaluation of strategic alternatives, the Merger Agreement is in the best interest of Romeo and its stockholders. As such, the Romeo Board recommends that Romeo stockholders tender their shares pursuant to the Offer.

If less than a majority of the outstanding shares of Romeo common stock are tendered, the Offer cannot be completed by Nikola.

Process for Romeo Stockholders to Tender their Shares

Alliance Advisors is acting as Information Agent for the Offer and Continental Stock Transfer & Trust Company is acting as Exchange Agent in the Offer. To request documents and assistance, Romeo Stockholders should call Alliance Advisors at (855) 643-7453 (Romeo stockholders call toll-free) or (973) 873-7700 (bankers and brokers call collect), or email [email protected].

If stockholders hold shares of Romeo common stock through a broker, dealer, commercial bank, trust company or other nominee, these shares can be tendered by instructing such broker or other nominee before the expiration September 26, 2022. Stockholders should contact their broker or other nominee promptly to allow sufficient time to tender.

Compelling Rationale for Stockholders to Tender to the Nikola Offer

  • Premium to Romeo’s Share Price: The proposed exchange ratio represents an approximately 34% premium to Romeo’s closing share price on July 29, 2022.
  • Board of Directors Unanimously Determined that the Nikola Transaction is in the Best Interest of Stockholders: Romeo’s Board of Directors conducted a comprehensive review of strategic alternatives. For a variety of reasons, including risks and uncertainties relating to ongoing industry consolidation and competition, liquidity challenges, and the desire for Romeo’s stakeholders to be able to share in future earnings or growth of Nikola, Romeo’s Board of Directors unanimously determined that a combination with Nikola is in the best interest of Romeo and its stockholders.
  • Ability for Stockholders to Participate in Long-Term Upside of a Stronger Combined Company: The Romeo Board of Directors believes that this combination offers the best opportunity for its stockholders to participate in the ongoing growth of Nikola and, indirectly, Romeo, including any potential appreciation that may be reflected in the value of the combined company (including any resulting synergies).

The recommendation is more completely described in Romeo’s Solicitation/Recommendation Statement on Schedule 14D-9 previously filed by Romeo with the Securities and Exchange Commission on August 29, 2022.

To participate in the exchange offer, Romeo stockholders must tender their shares of Romeo common stock to the Offer before its expiration at midnight, Eastern Time, at the end of September 26, 2022. A majority of shares of Romeo common stock are required to be tendered in order to complete the transaction, in addition to customary closing conditions.

About Romeo Power, Inc.

Founded in 2016 and headquartered in Cypress, California, Romeo (NYSE: RMO) is an energy storage technology company focused on designing and manufacturing lithium ion battery products and packs for vehicle electrification. Romeo’s suite of advanced battery electric products, combined with its innovative battery management system, delivers the safety, performance, reliability and configurability its customers need to succeed. To keep up with everything Romeo, follow Romeo on social media, @romeopowerinc or visit romeopower.com.

Additional Information and Where to Find It

This press release is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell shares.On August 29, 2022, Nikola Corporation (“Nikola”) filed a Registration Statement on Form S-4 (including a Prospectus/Offer to Exchange, a related Letter of Transmittal and other exchange offer documents with the U.S. Securities and Exchange Commission (the “SEC”) and may file additional amendments thereto, and Nikola and a wholly-owned subsidiary of Nikola filed a Tender Offer Statement on Schedule TO with the SEC and has and may file additional amendments thereto. In addition, on August 29, 2022, Romeo Power, Inc. (“Romeo”) filed a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC and has and may file amendments thereto. Nikola and Romeo may also file other documents with the SEC related to the transaction. This document is not a substitute for the Registration Statement, the Tender Offer Statement, the Solicitation/Recommendation Statement or any other document that Nikola or Romeo may file with the SEC related to the transaction (collectively, the “Exchange Offer Materials”). THE EXCHANGE OFFER MATERIALS CONTAIN IMPORTANT INFORMATION. ROMEO’S STOCKHOLDERS ARE URGED TO READ THESE DOCUMENTS CAREFULLY (AS EACH MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME) BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION THAT HOLDERS OF ROMEO’S SECURITIES SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING TENDERING THEIR SECURITIES. The Exchange Offer Materials are available to all holders of r Romeo’s common stock at no expense to them. The Exchange Offer Materials are available for free at the SEC’s website at www.sec.gov. Additional copies may be obtained for free by contacting Investor Relations, Corporate Secretary at Romeo Power, Inc., 4380 Ayers Avenue Vernon, CA 90058 (for documents filed by Romeo) or Investor Relations, Corporate Secretary at Nikola Corporation, 4141 E Broadway Road, Phoenix, Arizona 85040 (for documents filed by Nikola).

Forward-Looking Statements

This press release contains forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, related to Romeo and the acquisition of Romeo by Nikola that involves substantial risks, uncertainties and assumptions that could cause actual results to differ materially from those expressed or implied by such statements. Any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “should,” “could,” “would,” “expect,” “plan,” “anticipate,” “contemplate,” “intend,” “believe,” “estimate,” “continue,” “goal,” “project” or the negative of such terms or other similar terms. Forward-looking statements in this report include, among other things, statements about the potential benefits of the proposed transaction, Romeo’s plans, objectives, expectations and intentions, the financial condition, results of operations and business of Romeo, and the anticipated timing of closing of the proposed transaction. These forward-looking statements are subject to known and unknown risks, uncertainties and assumptions that could cause actual results to differ materially from those projected or otherwise implied by the forward-looking statements, including the following: risks related to the ability of Romeo to consummate the proposed transaction on a timely basis or at all; the satisfaction of the conditions precedent to consummation of the proposed transaction, including having a sufficient number of Romeo’s common stock being validly tendered into the exchange offer to meet the minimum condition; the ability to realize the anticipated benefits of the proposed transaction, including the possibility that the expected benefits from the proposed transaction will not be realized or will not be realized within the expected time period; disruption from the transaction making it more difficult to maintain business and operational relationships; the negative side effects of the announcement or the consummation of the proposed transaction on the market price of Romeo’s common stock or on Romeo’s operating results; significant transaction costs; unknown liabilities; the risk of litigation and/or regulatory actions related to the proposed transaction, risks that Romeo is unsuccessful in integrating potential acquired businesses and product lines; risks of decreased revenues due to pricing pressures or lower product volume ordered from customers; risks that our products, and services fail to interoperate with third-party systems; potential price increases or lack of availability of third-party technology, battery cells, components or other raw materials that we use in our products; potential disruption of our products, offerings, and networks; our ability to deliver products and services following a disaster or business continuity event; risks resulting from our international operations, including overseas supply chain partners; risks related to strategic alliances; risks related to our ability to raise additional capital in the future if required; potential unauthorized use of our products and technology by third parties; potential impairment charges related to our long-lived assets, including our fixed assets and equity method investments; changes in applicable laws or regulations, including tariffs and similar charges; potential failure to comply with privacy and information security regulations governing the client datasets we process and store; the possibility that the novel coronavirus pandemic may adversely affect our future results of operations, financial position and cash flows; the possibility that Russia’s invasion of Ukraine may result in continued price increases or lack of availability of certain raw materials; and the possibility that we may be adversely affected by other economic, business or competitive factors. The foregoing factors should not be construed as exhaustive and should be read together with the other cautionary statements included in this and other reports we file with or furnish to the SEC, including the information in “Item 1A. Risk Factors” included in Part I of our Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent quarterly reports on Form 10-Q. If one or more events related to these or other risks or uncertainties materialize, or if our underlying assumptions prove to be incorrect, actual results may differ materially from what we anticipate.

Nikola Media

Nicole Rose

[email protected]

480-660-6893

Colleen Robar

[email protected]

313-207-5960

Romeo Power Media

Chris Hodges or Joe Caminiti

[email protected]

312-445-2870

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Alternative Energy Energy Other Technology Technology Other Energy

MEDIA:

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Chicken Soup for the Soul Entertainment Announces Timing of Regular Monthly Dividend for October for Series A Cumulative Redeemable Perpetual Preferred Stock

Chicken Soup for the Soul Entertainment Announces Timing of Regular Monthly Dividend for October for Series A Cumulative Redeemable Perpetual Preferred Stock

COS COB, Conn.–(BUSINESS WIRE)–
Chicken Soup for the Soul Entertainment, Inc. (Nasdaq: CSSE, CSSEP, CSSEL, CSSEN), one of the largest operators of advertising-supported video-on-demand (AVOD) streaming services, today announced the timing for the payment of its declared regular monthly dividend of $0.2031 per share of its 9.75% Series A Cumulative Redeemable Perpetual Preferred Stock for October 2022. The dividend will be payable on October 15, 2022 to holders of record as of September 30, 2022. The dividend will be paid in cash.

ABOUT CHICKEN SOUP FOR THE SOUL ENTERTAINMENT

Chicken Soup for the Soul Entertainment, Inc. (Nasdaq: CSSE) operates video-on-demand streaming services (VOD). The company owns Crackle Plus, which owns and operates a variety of ad-supported VOD streaming services including Crackle, Chicken Soup for the Soul, and Popcornflix. The company also acquires and distributes video content through its Screen Media and 1091 Pictures subsidiaries and produces original video content through the Chicken Soup for the Soul Television Group. The company recently acquired Redbox which operates a rapidly growing digital streaming service that provides both ad-supported (AVOD) and paid movies from Hollywood studios and hundreds of content partners, as well as over 145 channels of free ad-supported streaming television (FAST). Redbox also operates its popular kiosks across the US at thousands of retail locations – giving consumers affordable access to the latest in entertainment. Chicken Soup for the Soul Entertainment is a subsidiary of Chicken Soup for the Soul, LLC, which publishes the famous book series and produces super-premium pet food under the Chicken Soup for the Soul brand name.

FORWARD-LOOKING STATEMENTS

This press release includes forward-looking statements within the meaning of the federal securities laws. Forward-looking statements are statements that are not historical facts. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of management and are not predictions of actual performance. Such assumptions involve a number of known and unknown risks and uncertainties, including but not limited to our core strategy, operating income and margin, seasonality, liquidity, including cash flows from operations, available funds, and access to financing sources, free cash flows, revenues, net income, profitability, stock price volatility, future regulatory changes, price changes, the ability of the Company’s content offerings to achieve market acceptance, the Company’s success in retaining or recruiting officers, key employees, or directors, the ability to protect intellectual property, the ability to complete strategic acquisitions, the ability to manage growth and integrate acquired operations, the ability to pay dividends, regulatory or operational risks, and general market conditions impacting demand for the Company’s services. For a more complete description of these and other risks and uncertainties, please refer the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, filed with the SEC on March 31, 2022, and, with respect to the Company’s recent acquisition of Redbox Entertainment, Inc. (“Redbox”), the Company’s Registration Statement on Form S-4 declared effective by the SEC on July 15, 2022. If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by the forward-looking statements contained in this press release. Information regarding the acquisition of Redbox and related transactions is qualified by reference to the Company’s Current Reports on Form 8-K filed with the SEC on May 11, 2022 (as amended May 12, 2022), June 6, 2022, and August 12, 2022, and all exhibits filed with respect to such reports and the aforementioned registration statement. The forward-looking statements contained in this press release speak only as of the date hereof and the Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

INVESTOR RELATIONS

Zaia Lawandow

Chicken Soup for the Soul Entertainment

[email protected]

MEDIA

Peter Binazeski

Chicken Soup for the Soul Entertainment Corporate

[email protected]

KEYWORDS: Connecticut United States North America

INDUSTRY KEYWORDS: Entertainment Communications Film & Motion Pictures TV and Radio General Entertainment Publishing Public Relations/Investor Relations

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Dillard’s Announces Style for a Cause

Dillard’s Announces Style for a Cause

Teams with V Foundation to Accelerate Victory Over Cancer®

LITTLE ROCK, Ark.–(BUSINESS WIRE)–
Dillard’s, Inc. (“Dillard’s”) (“the Company”) has announced its commitment to accelerating Victory Over Cancer® with Style for a Cause, launching September 19th in Dillard’s stores across the country.

Dillard’s will donate $2* of every regular priced purchase of handbags, watches, jewelry, sunglasses and ladies’ fashion accessories to the V Foundation for Cancer Research to fund game-changing cancer research.

Dillard’s Senior Vice President William Dillard, III, stated, “We are honored to partner with the V Foundation, founded by Jim Valvano and ESPN, to accelerate Victory Over Cancer. Cancer affects the lives of so many of our customers, associates and friends. Jim’s inspiring life and memorable words of courage live on in the V Foundation, and we are tremendously happy to launch Style for a Cause to join in the fight.”

Shane Jacobsen, CEO of the V Foundation, added, “I’m encouraged and excited. Dillard’s commitment to joining our team will make a difference in the lives of many impacted by cancer. Their donation through the Style for a Cause event will support the nation’s best research and will help save the lives of cancer patients. We are glad they are on our team working to achieve Victory Over Cancer.”

Dillard’s will host Style for a Cause in all locations September 19th – 25th. Visit your favorite Dillard’s store to celebrate style and join the V Foundation in the fight against cancer.

*up to $100,000 – in-store purchases only

About the V Foundation for Cancer Research

The V Foundation for Cancer Research was founded in 1993 by ESPN and the late Jim Valvano, legendary North Carolina State University basketball coach and ESPN commentator. The V Foundation has funded nearly $290 million in game-changing cancer research grants nationwide through a competitive process strictly supervised by a world-class Scientific Advisory Committee. Because the V Foundation has an endowment to cover administrative expenses, 100% of direct donations is awarded to cancer research and programs. The V team is committed to accelerating Victory Over Cancer®. To learn more, visit v.org.

About Dillard’s

Dillard’s was founded by William T. Dillard in 1938 in Nashville, Arkansas with an $8,000 investment in a hometown department store. Today, Dillard’s, Inc. ranks among the nation’s largest fashion retailers – operating 250 Dillard’s locations and 29 clearance centers spanning 29 states and an Internet store at dillards.com. The Company focuses on delivering style, quality and value to its customers by offering premium fashion apparel, beauty and home collections from both national and exclusive brand sources. Dillard’s complements this curated product assortment with exceptional, client-focused customer care.

Dillard’s, Inc.

Julie J. Guymon

501-376-5965

[email protected]

KEYWORDS: Arkansas United States North America

INDUSTRY KEYWORDS: Retail Health Entertainment Celebrity Other Philanthropy Philanthropy Oncology Department Stores Research Other Retail Fund Raising Foundation Science Fashion

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EQONEX expands its Investment Product offering with multi-currency Exchange-Traded Notes

PR Newswire

USD tranche of EQONEX Bitcoin Exchange Traded Note

(ETN) is available on Deutsche Börse XETRA Exchange from today

  • The EQONEX physically backed USD Bitcoin ETN (Ticker: EQ1C) offers investors direct exposure to bitcoin via an exchange-traded product
  • Investors to benefit from free redemptions for the underlying bitcoin and low management fees
  • Underlying Bitcoin is stored in EQONEX’s accredited custody provider, Digivault


FRANKFURT, Germany
, Sept. 16, 2022 /PRNewswire/ — EQONEX Limited (NASDAQ: EQOS) (the Group), a digital assets financial services company, is expanding its Investment Product offering with a USD denominated Bitcoin Exchange-Traded Note (ETN) available on the Deutsche Börse XETRA Exchange from today.   

The USD denominated EQONEX Bitcoin ETN follows hot on the footsteps of the inaugural Euro denominated version launched in July.  EQONEX received ETN prospectus approval from Germany’s Federal Financial Supervisory Authority (BaFin) and has a roadmap to offer a suite of crypto exchange-traded products in the near future.  

EQONEX Bitcoin ETNs provide direct investment exposure to bitcoin via an exchange-traded, physically-backed product. Investors can trade in and out of ETNs via their existing brokerage accounts with Euro or USD. The bitcoin underlying the ETN will be stored in the group’s Financial Conduct Authority (FCA) registered custody provider Digivault, which is one of only 35 exchange or custody providers to hold this accreditation.

Frank Copplestone, EQONEX Head of Investment Products said, “We were excited to offer our first Euro denominated Bitcoin ETN earlier this year. For many, the USD remains a default investment currency, so we were eager to prioritise a USD version which also bears our hallmark benefits such as free redemptions and secure custody”.

“Exchange-traded products provide investors with a familiar access point for gaining exposure to new asset classes such as bitcoin and we are looking forward to building out a multi-currency offering.”

Distinct from some other issuers, EQONEX embeds an additional investor protection by holding the underlying physical bitcoin in a segregated account under a Security Trustee structure, ensuring it is not used for rehypothecation.  

The bitcoin underpinning the EQONEX Bitcoin ETN is held in Digivault which means it is tested to ensure that it is legitimate and has not been tainted by money laundering or criminal activity.

Flow Traders B.V. will register with Deutsche Börse to perform the role of EQONEX’s Designated Sponsor which requires the fulfilment of certain stringent quality criteria regarding tradable volumes and bid-ask spreads.

About EQONEX

EQONEX Limited (NASDAQ: EQOS) is a technology-driven digital assets financial services group that provides institutional grade infrastructure and a full suite of custody and asset management solutions to clients. The Group’s digital assets ecosystem has been designed to accommodate the needs of institutions and individuals with the same degree of regulatory oversight and security they are accustomed to in traditional financial markets. EQONEX’s ecosystem includes Digivault, an FCA- registered custodian, Asset Management which encompasses investment products, and Bletchley Park, a fund of crypto-hedge funds. EQONEX also offers OTC and lending services and soon-to-be –launched Structured Products business.

For more information visit: https://group.eqonex.com/

Forward-Looking Information

Any forward-looking statements in this press release are based on available current market material and management’s expectations, beliefs and forecasts concerning future events impacting EQONEX.  You are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, as well as assumptions, which, if they were to ever materialize or prove incorrect, could cause the results of EQONEX to differ materially from those expressed or implied by such forward-looking statements.  The forward-looking statements made in this press release speak only as of the date hereof and we disclaim any obligation, except as required by law, to provide updates, revisions or amendments to any forward-looking statements to reflect changes in our expectations or future events.

 

Cision View original content:https://www.prnewswire.com/news-releases/eqonex-expands-its-investment-product-offering-with-multi-currency-exchange-traded-notes-301626148.html

SOURCE EQONEX

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National Fuel Declares Quarterly Dividend

WILLIAMSVILLE, N.Y., Sept. 16, 2022 (GLOBE NEWSWIRE) — Today, the National Fuel Gas Company (“National Fuel” or the “Company”) (NYSE:NFG) Board of Directors approved a regular quarterly dividend of 47.5 cents per share on the Company’s common stock. The dividend is payable Oct. 14, 2022, to stockholders of record at the close of business on Sept. 30, 2022.

The Company has approximately 91.5 million shares of common stock outstanding. It has no preferred stock outstanding.

National Fuel is a diversified energy company headquartered in Western New York that operates an integrated collection of natural gas assets across four business segments: Exploration & Production, Pipeline & Storage, Gathering, and Utility. Additional information about National Fuel is available at www.nationalfuel.com.



Analyst Contact: Brandon Haspett | 716-857-7697 
Media Contact: Karen Merkel | 716-857-7654

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Novavax Nuvaxovid™ COVID-19 Vaccine Receives Expanded Emergency Use Authorization in Taiwan for Use in Adolescents Aged 12 Through 17

PR Newswire


GAITHERSBURG, Md.
, Sept. 16, 2022 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the Taiwan Food and Drug Administration (TFDA) has granted expanded emergency use authorization (EUA) for Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adolescents aged 12 through 17.

“In Taiwan, we have seen strong use of our protein-based COVID-19 vaccine in adults and are pleased to expand availability to adolescents aged 12 through 17 as we prepare for more time spent indoors during the fall and winter months and possible COVID-19 surges,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “We believe that our vaccine, developed using an innovative approach to traditional technology, may help increase adolescent vaccination rates.”

The EUA is based on data from the ongoing pediatric expansion of the Phase 3 PREVENT-19 trial of 2,247 adolescents aged 12 through 17 years across 75 sites in the U.S., to evaluate the safety and effectiveness of Nuvaxovid. In the pediatric expansion, Nuvaxovid achieved its primary efficacy endpoint with clinical efficacy of 78.29% (95% CI: 37.55%, 92.45%) overall at a time when the Delta variant was the predominant circulating SARS-CoV-2 strain in the U.S. The efficacy analysis was supported by assessment of antibody titers that were shown to be higher in adolescents than in young adults.

Preliminary safety data from the pediatric expansion showed the vaccine to be generally well-tolerated. Serious and severe adverse reactions (AR) were low in number and balanced between vaccine and placebo groups, and not considered related to the vaccine. Local and systemic reactogenicity was generally lower than or similar to adults, after the first and second dose. Among participants 12 through 17 years of age, solicited ARs following administration of any dose of the vaccine were injection site pain/tenderness (75.0%), headache (56.9%), fatigue/malaise (57.9%), muscle pain (49.0%), nausea/vomiting (19.9%), joint pain (16.2%), fever (16.9%), injection site swelling (8.0%), and injection site redness (7.5%). Most were mild-to-moderate in severity and lasted less than two days. No new safety signal was observed through the placebo-controlled portion of the pediatric expansion.

In the 12 through 17-year-old population, the vaccine has been authorized in more than 10 markets including the U.S., the European Union, and the United Kingdom (U.K.).

The TFDA previously granted EUA for Nuvaxovid to prevent COVID-19 in adults aged 18 and older in June 2022.

Trade Name in the U.S. 

The trade name Nuvaxovid™ has not yet been approved by the U.S. Food and Drug Administration (FDA).

Important Safety Information
  • Nuvaxovid is contraindicated in persons who have a hypersensitivity to the active substance, or to any of the excipients.
  • Events of anaphylaxis have been reported with administration of COVID-19 vaccines. Appropriate medical treatment and supervision should be available in case of an anaphylactic reaction following the administration of the vaccine. Close observation for at least 15 minutes is recommended and a second dose of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of the vaccine.
  • Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation, or stress‐related reactions may occur in association with vaccination as a psychogenic response to the needle injection. It is important that precautions are in place to avoid injury from fainting.
  • Vaccination should be postponed in individuals suffering from an acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination.
  • Nuvaxovid should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals.
  • The efficacy of Nuvaxovid may be lower in immunosuppressed individuals.
  • Administration of Nuvaxovid in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus.
  • The effects with Nuvaxovid may temporarily affect the ability to drive or use machines.
  • Individuals may not be fully protected until seven days after their second dose. As with all vaccines, vaccination with Nuvaxovid may not protect all vaccine recipients.
  • The most frequent adverse reactions in adolescents 12 to 17 years of age were injection site tenderness, injection site pain, headache, myalgia, fatigue, malaise, nausea or vomiting, arthralgia, injection site swelling, pyrexia, and injection site redness.

For more information on NVX-CoV2373 please visit the following website:

About Nuvaxovid™ (NVX-CoV2373)

Nuvaxovid is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. The vaccine was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Nuvaxovid contains purified protein antigen and can neither replicate, nor can it cause COVID-19.

Nuvaxovid is packaged as a ready-to-use liquid formulation in a vial containing 10 doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. Use of the vaccine should be in accordance with official recommendations.

Novavax has established partnerships for the manufacture, commercialization, and distribution of Nuvaxovid worldwide. Existing authorizations leverage Novavax’ manufacturing partnership with Serum Institute of India, the world’s largest vaccine manufacturer by volume. They will later be supplemented with data from additional manufacturing sites throughout Novavax’ global supply chain.

About NVX-CoV2373 Phase 3 Trials

NVX-CoV2373 continues being evaluated in two pivotal Phase 3 trials.

PREVENT-19 (the PRE-fusion protein subunit Vaccine Efficacy Novavax Trial | COVID-19) is a 2:1 randomized, placebo-controlled, observer-blinded trial to evaluate the efficacy, safety, and immunogenicity of NVX-CoV2373 with Matrix-M adjuvant in 29,960 participants 18 years of age and over in 119 locations in the U.S. and Mexico. The primary endpoint for PREVENT-19 was the first occurrence of PCR-confirmed symptomatic (mild, moderate, or severe) COVID-19 with onset at least seven days after the second dose in serologically negative (to SARS-CoV-2) adult participants at baseline. The statistical success criterion included a lower bound of 95% CI >30%. A secondary endpoint was the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19. Both endpoints were assessed at least seven days after the second study vaccination in volunteers who had not been previously infected with SARS-CoV-2. In the trial, NVX-CoV2373 achieved 90.4% efficacy overall. It was generally well-tolerated and elicited a robust antibody response after the second dose in both studies. Full results of the trial were published in the New England Journal of Medicine (NEJM).

The pediatric expansion of PREVENT-19 is a 2:1 randomized, placebo-controlled, observer-blinded trial to evaluate the safety, effectiveness, and efficacy of NVX-CoV2373 with Matrix-M adjuvant in 2,247 adolescent participants 12 to 17 years of age in 73 locations in the U.S., compared with placebo. In the pediatric trial, the vaccine achieved its primary effectiveness endpoint (non-inferiority of the neutralizing antibody response compared to young adult participants 18 through 25 years of age from PREVENT-19) and demonstrated 80% efficacy overall at a time when the Delta variant of concern was the predominant circulating strain in the U.S. Additionally, immune responses were about two-to-three-fold higher in adolescents than in adults against all variants studied.

Additionally, a trial conducted in the U.K. with 14,039 participants aged 18 years and over was designed as a randomized, placebo-controlled, observer-blinded study and achieved overall efficacy of 89.7%. The primary endpoint was based on the first occurrence of PCR-confirmed symptomatic (mild, moderate, or severe) COVID-19 with onset at least seven days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline. Full results of the trial were published in NEJM.

About Matrix-M™ Adjuvant

Novavax’ patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

About Novavax

Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. The company’s proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. The Novavax COVID-19 vaccine, has received authorization from multiple regulatory authorities globally, including the U.S. FDA, the European Commission, and the World Health Organization. The vaccine is currently under review by multiple regulatory agencies worldwide, including for additional indications and populations such as adolescents and as a booster. In addition to its COVID-19 vaccine, Novavax is also currently evaluating its COVID-19-Influenza Combination vaccine candidate in a Phase 1/2 clinical trial, its quadrivalent influenza investigational vaccine candidate, and an Omicron strain-based vaccine (NVX-CoV2515) as well as a bivalent format Omicron-based / original strain-based vaccine. These vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

For more information, visit www.novavax.com and connect with us on LinkedIn.

Forward-Looking Statements

Statements herein relating to the future of Novavax, its operating plans and prospects, its partnerships, the timing of clinical trial results, the ongoing development of NVX-CoV2373, NVX-CoV2515 and bivalent Omicron-based / original strain based vaccine, a COVID-seasonal influenza combination investigational vaccine candidate, a quadrivalent influenza investigational vaccine candidate, the scope, timing and outcome of future regulatory filings and actions, including Novavax’ plans to supplement existing authorizations with data from the additional manufacturing sites in Novavax’ global supply chain, additional worldwide authorizations of NVX-CoV2373 for use in adults and adolescents, and as a booster, the evolving COVID-19 pandemic, the potential impact and reach of Novavax and NVX-CoV2373 in addressing vaccine access, controlling the pandemic and protecting populations, the efficacy, safety intended utilization, and the expected administration of NVX-CoV2373 are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; unanticipated challenges or delays in conducting clinical trials; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; and those other risk factors identified in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Novavax’ Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov and www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Contacts:

Investors
Erika Schultz | 240-268-2022
[email protected]

Media

Ali Chartan or Giovanna Chandler | 202-709-5563 
[email protected]

 

 

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/novavax-nuvaxovid-covid-19-vaccine-receives-expanded-emergency-use-authorization-in-taiwan-for-use-in-adolescents-aged-12-through-17-301626133.html

SOURCE Novavax, Inc.

Posted on

Norwood Financial Corp Announces Cash Dividend

HONESDALE, Pa., Sept. 16, 2022 (GLOBE NEWSWIRE) — James O. Donnelly, President and Chief Executive Officer of Norwood Financial Corp (NASDAQ Global Market – NWFL) and its subsidiary Wayne Bank, announced that the Board of Directors declared a $.28 per share cash dividend, which is payable November 1, 2022 to shareholders of record as of October 14, 2022. The $.28 per share equals the per share dividend declared in the prior quarter, and represents a 7.7% increase over the cash dividend declared in the third quarter of 2021.

Mr. Donnelly commented, “The Board is extremely pleased to provide our shareholders with this quarterly dividend. It reflects the Company’s financial strength and strong capital position which has contributed to our solid performance.”

Norwood Financial Corp, through its subsidiary, Wayne Bank operates fourteen offices in Northeastern Pennsylvania and fifteen offices in Delaware, Sullivan, Ontario, Otsego and Yates Counties, New York. As of June 30, 2022, Norwood had total assets of $2.066 billion, loans outstanding of $1.404 billion, total deposits of $1.800 billion and total capital of $173.8 million. The Company’s stock is traded on the Nasdaq Global Market under the symbol “NWFL”.

Forward-Looking Statements.
The foregoing material may contain forward-looking statements. We caution that such statements may be subject to a number of risks and uncertainties which may cause actual results to differ materially from those currently anticipated, and therefore readers should not place undue reliance on any forward looking statements. Those risks and uncertainties include, but are not limited to, our ability to pay or increase cash dividends in the future, the continued financial strength, solid performance and strong capital position of the Company, changes in federal and state laws, changes in the absolute and relative levels of interest rates, the potential adverse impact the COVID-19 pandemic may have on Norwood’s financial condition and results of operations, the ability to control costs and expenses, demand for real estate, costs associated with cybercrime, general economic conditions and the effectiveness of governmental responses thereto. Norwood Financial Corp does not undertake and specifically disclaims any obligation to publicly release the results of any revisions that may be made to any forward-looking statements to reflect the occurrence of anticipated or unanticipated events or circumstances after the date of such statements.

CONTACT:   William Lance
Executive Vice President and Chief Financial Officer
NORWOOD FINANCIAL CORP
(570) 253-8505
www.waynebank.com



Posted on

Novavax Nuvaxovid™ COVID-19 Vaccine Now Available in Israel for Individuals Aged 12 and Older

PR Newswire

  • The Israeli Advisory Committee on Epidemics has recommended that Nuvaxovid™ be approved for ages 12 and older as a primary series and as a heterologous booster for those previously vaccinated with mRNA vaccines


GAITHERSBURG, Md.
, Sept. 16, 2022 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the Israel Ministry of Health has granted an import and use permit which provides individuals aged 12 and older access to the Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as a primary series and as a heterologous booster for those previously vaccinated with mRNA vaccines. The permit is based on the Israeli Advisory Committee on Epidemics’ recommendation.

“Today’s milestone provides the people of Israel a protein-based COVID-19 vaccine developed using an innovative approach to traditional technology,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “Nuvaxovid is now available for use in Israel in individuals aged 12 and older as both a primary series and a booster regardless of previous vaccine history.”

Nuvaxovid has received authorization for use in adults aged 18 and older from more than 40 markets, including the U.S. and from the World Health Organization. In the 12 through 17 year-old population, the vaccine has been authorized in more than 10 markets including the U.S., the European Union, and the United Kingdom. Nuvaxovid has also been authorized in the European Union, Japan, Australia, New Zealand, and Switzerland as a booster in adults aged 18 and older. The vaccine is actively under review in other markets.

Trade Name in the U.S.

The trade name Nuvaxovid™ has not yet been approved by the U.S. Food and Drug Administration.

Important Safety Information
  • Nuvaxovid is contraindicated in persons who have a hypersensitivity to the active substance, or to any of the excipients.
  • Events of anaphylaxis have been reported with administration of COVID-19 vaccines. Appropriate medical treatment and supervision should be available in case of an anaphylactic reaction following the administration of the vaccine. Close observation for at least 15 minutes is recommended and a second dose of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of Nuvaxovid.
  • Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation, or stress‐related reactions may occur in association with vaccination as a psychogenic response to the needle injection. It is important that precautions are in place to avoid injury from fainting.
  • Vaccination should be postponed in individuals suffering from an acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination.
  • Nuvaxovid should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals.
  • The efficacy of Nuvaxovid may be lower in immunosuppressed individuals.
  • Administration of Nuvaxovid in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus.
  • The effects with Nuvaxovid may temporarily affect the ability to drive or use machines.
  • Individuals may not be fully protected until seven days after their second dose. As with all vaccines, vaccination with Nuvaxovid may not protect all vaccine recipients.
  • The most common adverse reactions observed during clinical studies were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise.

For more information on Nuvaxovid, including the Summary of Product Characteristics with Package Leaflet, Prescribing Information and Important Safety Information, adverse event reporting instructions, or to request additional information, please visit the following website: 

About Nuvaxovid™ (NVX-CoV2373) 

Nuvaxovid (NVX-CoV2373) is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. The vaccine was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Nuvaxovid contains purified protein antigen and can neither replicate, nor can it cause COVID-19.  

Nuvaxovid is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. Use of the vaccine should be in accordance with official recommendations.  

Novavax has established partnerships for the manufacture, commercialization, and distribution of Nuvaxovid worldwide. Existing authorizations leverage Novavax’ manufacturing partnership with Serum Institute of India, the world’s largest vaccine manufacturer by volume. They will later be supplemented with data from additional manufacturing sites throughout Novavax’ global supply chain.

About the Novavax COVID-19 vaccine (NVX-CoV2373) Phase 3 Trials

The Novavax COVID-19 vaccine (NVX-CoV2373) continues being evaluated in two pivotal Phase 3 trials. 

PREVENT-19 (the PRE-fusion protein subunit Vaccine Efficacy Novavax Trial | COVID-19) is a 2:1 randomized, placebo-controlled, observer-blinded trial to evaluate the efficacy, safety and immunogenicity of the Novavax COVID-19 vaccine with Matrix-M adjuvant in 29,960 participants 18 years of age and over in 119 locations in the U.S. and Mexico. The primary endpoint for PREVENT-19 was the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least seven days after the second dose in serologically negative (to SARS-CoV-2) adult participants at baseline. The statistical success criterion included a lower bound of 95% CI >30%. A secondary endpoint was the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19. Both endpoints were assessed at least seven days after the second study vaccination in volunteers who had not been previously infected with SARS-CoV-2. In the trial, the Novavax COVID-19 vaccine achieved 90.4% efficacy overall. It was generally well-tolerated and elicited a robust antibody response after the second dose in both studies. Full results of the trial were published in the New England Journal of Medicine (NEJM). 

The pediatric expansion of PREVENT-19 is a 2:1 randomized, placebo-controlled, observer-blinded trial to evaluate the safety, effectiveness, and efficacy of the Novavax COVID-19 vaccine with Matrix-M adjuvant in 2,247 adolescent participants 12 to 17 years of age in 73 locations in the United States, compared with placebo. In the pediatric trial, the vaccine achieved its primary effectiveness endpoint (non-inferiority of the neutralizing antibody response compared to young adult participants 18 through 25 years of age from PREVENT-19) and demonstrated 80% efficacy overall at a time when the Delta variant of concern was the predominant circulating strain in the U.S. Additionally, immune responses were about two-to-three-fold higher in adolescents than in adults against all variants studied. 

Additionally, a trial conducted in the U.K. with 14,039 participants aged 18 years and over was designed as a randomized, placebo-controlled, observer-blinded study and achieved overall efficacy of 89.7%. The primary endpoint was based on the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least seven days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline. Full results of the trial were published in NEJM.

About Matrix-M™ Adjuvant

Novavax’ patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response. 

About Novavax

Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. The company’s proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. The Novavax COVID-19 vaccine, has received authorization from multiple regulatory authorities globally, including the U.S. Food and Drug Administration, the European Commission, and the WHO. The vaccine is currently under review by multiple regulatory agencies worldwide, including for additional indications and populations such as adolescents and as a booster. In addition to its COVID-19 vaccine, Novavax is also currently evaluating its COVID-19-Influenza Combination vaccine candidate in a Phase 1/2 clinical trial, its quadrivalent influenza investigational vaccine candidate, and an Omicron strain-based vaccine (NVX-CoV2515) as well as a bivalent format Omicron-based / original strain-based vaccine. These vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.  

For more information, visit www.novavax.com and connect with us on LinkedIn. 

Forward-Looking Statements

Statements herein relating to the future of Novavax, its operating plans and prospects, its partnerships, the timing of clinical trial results, the ongoing development of NVX-CoV2373, including an Omicron strain based vaccine and bivalent Omicron-based / original strain based vaccine, a COVID-seasonal influenza combination investigational vaccine candidate, a quadrivalent influenza investigational vaccine candidate, the scope, timing and outcome of future regulatory filings and actions, including Novavax’ plans to supplement existing authorizations with data from the additional manufacturing sites in Novavax’ global supply chain, additional worldwide authorizations of NVX-CoV2373 for use in adults and adolescents, and as a booster, the potential impact and reach of Novavax and NVX-CoV2373 in addressing vaccine access, controlling the pandemic and protecting populations, the efficacy, safety intended utilization, and expected administration of NVX-CoV2373 are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; unanticipated challenges or delays in conducting clinical trials; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; and those other risk factors identified in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Novavax’ Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov and www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Contacts:

Investors

Erika Schultz | 240-268-2022
[email protected]

Media

Ali Chartan or Giovanna Chandler | 202-709-5563
[email protected]

 

 

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/novavax-nuvaxovid-covid-19-vaccine-now-available-in-israel-for-individuals-aged-12-and-older-301626126.html

SOURCE Novavax, Inc.